UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019805 |
|---|---|
| Receipt number | R000022829 |
| Scientific Title | A study on the effect of rehabilitative intervention on childhood cancer during and after treatment |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2020/06/02 10:33:38 |
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Basic information
Public title
A study on the effect of rehabilitative intervention on childhood cancer during and after treatment
Acronym
Effective rehabilitation for children with cancer
Scientific Title
A study on the effect of rehabilitative intervention on childhood cancer during and after treatment
Scientific Title:Acronym
Effective rehabilitation for children with cancer
Region
| Japan |
Condition
Condition
childhood cencer
Classification by specialty
| Pediatrics | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the period of effective rehabilitation intervention for pediatric cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Six-minute walk test: before and after cancer therapy, then after one year
Key secondary outcomes
Grip strength; Knee extension strength; One leg stand test; Timed up and go test; New physical fitness test of Japanese MEXT; Wechsler intelligence scale; Functional independence measure/functional assessment measure; Pediatric quality of life inventory; body composition; biochemical data; brain imaging
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Early rehabilitation (simultaneously with the start of cancer treatment)
Interventions/Control_2
Traditional rehabilitation (start from tapering phase of cancer treatment)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 5 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with cancer
Cancer therapy and hospitalization
Key exclusion criteria
Severe developmental disorder
Communication disorder
Astasia-abasia
Severe exercise-induced asthma
The terminal phase of the disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuma Sonoda |
Organization
Shiga University of Medical Science Hospital
Division name
Rehabilitation Units
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2670
yuma@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuma Sonoda |
Organization
Shiga University of Medical Science Hospital
Division name
Rehabilitation Units
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2670
Homepage URL
yuma@belle.shiga-med.ac.jp
Sponsor or person
Institute
Rehabilitation Units, Shiga University of Medical Science Hospital
Institute
Department
Personal name
Funding Source
Organization
Rehabilitation Units, Shiga University of Medical Science Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pediatrics, Shiga University of Medical Science Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2020 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022829
